Dako Autostainer instruments: Autostainer Link 48, Model AS480; Autostainer Plus Link Instrument, Model AS100; Autostainer, Model S3400; and Autostainer Plus, Model S3800.
Enforcement
- Recall Number
- Z-2074-2020
- Event ID
- 84465
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Dako Denmark A/S
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- May 27, 2020
- Initiation Date
- November 5, 2019
- Classification Date
- May 21, 2020
- Termination Date
- May 17, 2022
- Address
- Produktionsvej 42, N/A, Glostrup, N/A, N/A, Denmark
Description
Dako Autostainer instruments: Autostainer Link 48, Model AS480; Autostainer Plus Link Instrument, Model AS100; Autostainer, Model S3400; and Autostainer Plus, Model S3800.
The Autostainer instrument may not have a syringe tray installed which could result in a small volume of excess buffer being applied to several slides. In addition to the syringe tray, the updated Basic User Guide will reduce the potential risk of false negative results in the case of leakage of buffer and/or reagents that may impact staining.
All serial numbers of devices manufactured between 7/22/1997-6/28/2018 that do not have an installed syringe tray, UDI 05700572035497.
Distribution was nationwide. There was government/military distribution. Foreign distribution was made to Canada, Australia, Bangaladesh, Belarus, Brazil, Bulgaria, Chile, China, Colombia, Croatia, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Macedonia, Morocco, New Zealand, Norway, Oman, Pakistan, Panama, Peru, Poland, Qatar, Romania, Russia, Saudi Arabia, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, Uruguay, and Vietnam.
796 devices